Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InZone IST Detachment System; IZDS Connecting Cable

K-Number: K251832 · 2025-10-17

ApplicantStryker Neurovascular
Decision Date2025-10-17
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

InZone IST Detachment System; IZDS Connecting Cable is a medical device manufactured by Stryker Neurovascular. It received FDA 510(k) clearance on 2025-10-17 under approval number K251832. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InZone IST Detachment System; IZDS Connecting Cable?

InZone IST Detachment System; IZDS Connecting Cable is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Stryker Neurovascular. The 510(k) number is K251832.

When was InZone IST Detachment System; IZDS Connecting Cable approved by the FDA?

InZone IST Detachment System; IZDS Connecting Cable received FDA 510(k) clearance on 2025-10-17, under approval number K251832.

What company makes InZone IST Detachment System; IZDS Connecting Cable?

InZone IST Detachment System; IZDS Connecting Cable is manufactured by Stryker Neurovascular.

What is the FDA product code for InZone IST Detachment System; IZDS Connecting Cable?

The FDA product code for InZone IST Detachment System; IZDS Connecting Cable is HCG.

Related Clinical Trials

NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT04057352 Citadel Embolization Device Study ACTIVE_NOT_RECRUITING

Other Devices by Stryker Neurovascular

K161429Target Detachable Coils K153658Target Detachable Coils K160096InZone Detachment System K163259AXS Offset Delivery Assist Catheter K190833AXS Vecta Aspiration Catheter K193034AXS Infinity LS Plus Long Sheath

View all 26 devices →

Related Devices (Code: HCG)

K161367HydroCoil Embolic System (HES)MicroVention, Inc. K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160832Penumbra Smart CoilPenumbra, Inc. K160096InZone Detachment SystemStryker Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑